510(k) K131810

OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM by Osseus Fusion Systems, LLC — Product Code MNH

K131810 is an FDA 510(k) premarket notification submitted by Osseus Fusion Systems, LLC for the device "OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM". The FDA issued a decision of Substantially Equivalent on Aug 8, 2013. The device falls under product code MNH (Orthosis, Spondylolisthesis Spinal Fixation), a Class II device regulated under 21 CFR 888.3070. Osseus Fusion Systems, LLC has 9 other 510(k) clearances on record.